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Important warning about Rituxan

The FDA has issued a public health advisory warning about the use of Rituxan after two lupus patients who received Rituxan died of a brain infection called progressive multifocal leukoencephalopathy, or PML. The FDA is urging all doctors to discuss the risk of PML with Rituxan patients. There is no known treatment for PML and it is usually fatal if contracted. Warning symptoms include confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems. Of course, most lupus patients have those anyway as a result of the disease, but any one taking Rituxan should be especially alert. Biogen and Genentech have sent warning letters to doctors - just wanted to make sure all you guys were aware of it too.

Well, any drug has its own set of risks and benefits - it wouldn't be so scary if this particular disease weren't usually fatal. But Rituxan is not a first-line treatment for lupus - the people who are taking it are (or should be) people who have severe disease that is threatening their organs or their life, who haven't responded well to other medications like cellcept. It's not appropriate for people who don't have organ-threatening disease, or people whose lupus can be managed with other medications with fewer risks. So, right now at least, it should probably be a last-choice drug, not a first-choice drug. Methotrexate has its own set of side effects, but it's been well studied - most of the risks of long term use are known, and some of the side effects can be eliminated or managed with folic acid supplements. Just make sure to talk up front with your doctor about the side effects and any potential risks. and definitely talk to them about folic acid supplements, which are very important with methotrexate.

Rituxan question

Hi Marycain
I just read your post. It scared me alot. Do you know if the people who developed this complication developed it right away after the infusion - or was it a longer term thing?
I took Rituxan in august and it seemed to help my kidneys, blood and fatigue to a certain extent. I took it because I didn't respond to or developed severe nausea with other standard drugs (cellcept, imuran, methotrexate, etc.) I think I am heading into another big flare and was going to ask about another infusion....ANyhow just curious if you have any more details. I certainly have some of the mental /fog issues as well.
thanks
Karen

From what I could gather from the FDA database, the infection can develop even a year after the last date of infusion - it doesn't appear to be related to how much Rituxan you've taken. The risk of developing PML seems to increase in patients who have had lupus five years or longer. PML has also been reported in lupus patients who were on cytoxan, but these are the first lupus cases linked to Rituxan. There have been other cases of PML in patients taking Rituxan for treatment of cancer, but none far in people taking it for RA. Of course, RA affects the immune system differently.

Because about 80% of the people in the world have been exposed to the latent virus, JCV, there is no practical way to test for the underlying virus, because just about everyone has antibodies to the JC virus. In normal healthy people this isn't a problem. But in people whose immune systems are severely impaired, like AIDS/HIV patients, people with some cancers, or people taking immune-suppressant drugs, the latent virus can become active (this is called an opportunistic infection), and attack the brain, destroying the cells (oligodendrocytes) that produce myelin, which is needed to form the sheath that surrounds and protects nerves.

Even though this is a really scary disease, so far it is just 2 patients out of maybe 10,000 lupus patients who have been treated with this drug. So unless more cases turn up as more lupus patients take the drug, it's hard to really quantify the risk. If you have organ involvement and nothing else works, then the benefits to you probably outweigh the risk of developing PML. I certainly feel that way about cytoxan, even though I know it has major risks, it's better than progressive kidney and CNS disease. But you know your disease better than anyone, so you know if you really need the drug. And from a practical standpoint, you've already incurred the risk by taking the drug. So the question you need to ask the doctors is whether anything in the literature suggests that the risk is dose-related (in other words, the more you take, the higher the risk). I'm trying to find out more information about the two patients who died, but becausr of medical privacy issues, there isn't much available. But I will let you know if I find out anything else.

My doctor had recommended it as an alterative to cytoxan, because it is supposed to last longer. but my insurer wouldn't pay for it , even though cytoxan treatment is just as expensive. I guess maybe I'm glad now they wouldn't. Hopefully imuran will do the trick for you.